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Description of key information

Oneda et al. 1994 found no tumorigenic effects in mice exposed to aluminum potassium sulfate.

Key value for chemical safety assessment

Justification for classification or non-classification

DSD: not classified

CLP: not classified

Additional information

Oneda et al. 1994 exposed B6C3F1 mice to aluminium potassium sulphate in the diet in a 20 -month chronic toxicity and tumorigenicity study. The dose levels used in the chronic study were 10% (w/w in the diet), 5.0%, 2.5% and 1.0% administered for a period of 20 months. These dose levels were chosen based on results from a preliminary acute toxicity study. An earlier acute toxicity study by the same investigators found an oral LD50 of 3672.5 mg/kg bw in males and 4400.9 mg/kg bw in females. Food consumption, growth, organ weight and histopathology were examined in 60 mice per dose-sex category. The level of aluminium in the basal diet was not reported nor the actual food consumption. The highest dose administered corresponded to 979 mg Al/kg bw/day [ATSDR (Agency for Toxic Substances and Disease Registry), Toxicological Profile for Aluminum, Atlanta, GA. US Department of Health and Human Services 2008].

All groups of APS treated mice tended to have increased survival rates relative to the controls. The incidence of tumors in the lower dose groups (1.0 -5.0% w/w) in both males and females was not significantly different from the controls. In the highest dose group (10% w/w), the tumor rate was significantly lower, particularly in males. The liver cancer rate was 5.3% in this dose group in males compared with 20.5% in the control group. Of interest was the difference in rates of liver cancer in males compared to females in the control and lower dose groups. Rates were higher in males for all 4 doses including controls. This study provides evidence for an absence of an tumorigenic effect.

Systemic carcinogenic effects from exposure specifically to aluminium or its compounds have not been investigated in epidemiological studies. The overall available data from human and animal studies provide no clear evidence for systemic carcinogenic effects on exposure to aluminium [ATSDR (Agency for Toxic Substances and Disease Registry), Toxicological Profile for Aluminum, Atlanta, GA. US Department of Health and Human Services 2008] and [Krewski D, Yokel RA, Nieboer E et al. Human health risk assessment for aluminium, aluminium oxide and aluminium hydroxide. J Toxicol Environ Health Part B 2007; 10: 1 -269].